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NCT00700830 Clinical Trial

Observational Study to Evaluate the Safety and Efficacy of Levemir® in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— IDEALS  

Official title:
Assessment of Safety and Efficacy of Levemir® (Insulin Detemir) Treatment for Insulin Naive Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00700830
Other study ID # NN304-3571
Secondary ID
Status Completed
Phase N/A
First received June 18, 2008
Last updated August 13, 2014
Start date January 2008
Est. completion date September 2009

Study information
Verified date December 2013
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Algeria: Ministry of Health
Study type Observational

Clinical Trial Summary

This study is conducted in Africa. The aim of this study is to assess the safety and efficacy of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical practice conditions in Algeria.

Recruitment information / eligibility
Status Completed
Enrollment 1976
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Informed consent obtained before any trial-related activities

- Type 2 diabetes

- HbA1c between 7-9%

- Insulin naive

- Inadequate control with oral antidiabetics therapy as judged by investigator

Exclusion Criteria:

- Patients with type 1 diabetes

- Hypersensitivity to Levemir® or to any of the excipients

- Pregnancy, or desire of pregnancy within next 6 months

- HbA1c greater than or equal to 9%

- Known or suspected allergy to the trial product or to any of the excipients

- Subjects who are unlikely to comply with protocol

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• insulin detemir
Initial dosage and the following dosages will be prescribed by the physician as a result of a normal clinical evaluation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Algeria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment the incidence of the Serious Adverse Events including the major Hypoglycaemia. During study Yes
Secondary HbA1c after 12 weeks (3 months) AND after 24 weeks (6 months) No
Secondary FBG (Fasting Blood Glucose) Monthly average for each month, and average of the past quarter No
Secondary Weight after 12 weeks (3 months) AND after 24 weeks (6 months) No
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